ADM Purified Pharmaceutical GMP Olive Oil with DMF, EP/USP (Refined Olive Oil IV)

As with many plant-based excipients, source variability could be a concern. Therefore, we manage the variability of our Refined Olive Oil IV by closely working with source suppliers. Our 9-step purification process guarantees high quality and consistency of the final product for your formulations, from topical to intravenous applications

• Manufactured under cGMP according to the ICH-Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
• A 9-step purification process is applied to the starting material (virgin olive oil) to deliver a high-quality purified oil. Final steps of the process, including fine filtration and drum filling under nitrogen, are performed in an ISO 8 class cleanroom.
• Supported with Certificate of Suitability to the European Pharmacopeia (CEP) granted by the European Directorate for the Quality of Medicines & Healthcare (EDQM) certifying that the substance is suitably manufactured and controlled according to the current version of the monograph Olive Oil, refined (1456).
• Supported with Drug Master File (DMF) type IV for excipients submitted to the U.S. Food and Drug Administration (FDA). (DMF # 034 152)

ADM-SIO’s Refined Olive Oil IV is available in 56.5 Kg or 200 Kg tight-head metal drums that are filled under nitrogen in an ISO 8-classified cleanroom.

Stability studies performed according to the International Conference on Harmonization (ICH) Q1A Quality. Guideline show that Refined Olive Oil IV is perfectly stable over a 36-month shelf life period.